Manufacturing Process Engineer

Katalyst CRO; Rockford (IL); On-site; USD 85,000 - 120,000; Full time

Job summary

Katalyst CRO is seeking a Manufacturing Process Engineer to develop, optimize, and validate production processes in a fast-paced facility in Rockford, IL. You will work cross-functionally with Manufacturing, Quality, R&D, and Supply Chain to implement improvements and ensure compliance with GMP/cGMP standards.

The role emphasizes process validation, CAPA, documentation, and NPI support, with opportunities to lead equipment validation and continuous improvement initiatives.

Qualifications

• Bachelor's degree in an engineering discipline (e.g., Manufacturing, Mechanical, Industrial, Chemical).
• 5+ years of manufacturing or process engineering experience in regulated/high-volume environments.
• Experience with Lean Manufacturing, Six Sigma, and CI methodologies.
• Experience with process validation, root cause analysis, and problem-solving techniques.
• Strong documentation and engineering change control knowledge.
• Excellent analytical, organizational, and communication skills.

Responsibilities

• Develop, implement, and optimize manufacturing processes to improve productivity, quality, and cost efficiency.
• Analyze manufacturing workflows and identify opportunities for process improvements using Lean Manufacturing and Six Sigma.
• Support new product introduction (NPI), process development, and technology transfer activities.
• Design, validate, and document manufacturing processes, including IQ, OQ, and PQ where applicable.
• Investigate production issues, perform root cause analysis, and implement CAPA.
• Create and maintain process documentation, SOPs, and manufacturing specifications.
• Collaborate with cross-functional teams including Mfg, QA, R&D, Maintenance, Supply Chain, and Regulatory Affairs.
• Support equipment selection, installation, commissioning, and validation activities.
• Monitor process performance using SPC and process capability analysis.
• Lead CI initiatives focused on cycle time reduction, waste elimination, yield improvement, and cost savings.
• Participate in FMEA, risk assessments, and process validation activities.
• Train manufacturing personnel on new processes, equipment, and standardized work procedures.
• Prepare technical reports, engineering documentation, and project status updates.

Skills

Lean Manufacturing

Six Sigma

Continuous Improvement

Process Validation

Data Analysis

Documentation

Cross-functional Collaboration

Regulatory Compliance

Education

Bachelor's degree in Manufacturing Engineering

Bachelor's degree in Mechanical Engineering

Tools

SolidWorks

AutoCAD

ERP systems

MES

Job description

Job Description

We are seeking a Manufacturing Process Engineer to support manufacturing operations by developing, optimizing, and validating production processes to improve efficiency, quality, and productivity. The ideal candidate will work closely with Manufacturing, Quality, Operations, R&D, and Supply Chain teams to drive continuous improvement initiatives, resolve production issues, and ensure compliance with safety and regulatory requirements in a fast-paced manufacturing environment.

Roles & Responsibilities

• Develop, implement, and optimize manufacturing processes to improve productivity, quality, and cost efficiency.
• Analyze manufacturing workflows and identify opportunities for process improvements using Lean Manufacturing and Six Sigma methodologies.
• Support new product introduction (NPI), process development, and technology transfer activities.
• Design, validate, and document manufacturing processes, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), where applicable.
• Investigate production issues, perform root cause analysis, and implement corrective and preventive actions (CAPA).
• Create and maintain process documentation, work instructions, Standard Operating Procedures (SOPs), and manufacturing specifications.
• Collaborate with cross-functional teams including Manufacturing, Quality Assurance, R&D, Maintenance, Supply Chain, and Regulatory Affairs.
• Support equipment selection, installation, commissioning, and validation activities.
• Monitor process performance using statistical tools such as Statistical Process Control (SPC) and process capability analysis.
• Lead continuous improvement initiatives focused on cycle time reduction, waste elimination, yield improvement, and cost savings.
• Participate in Failure Mode and Effects Analysis (FMEA), risk assessments, and process validation activities.
• Support manufacturing scale-up, process transfers, and production line improvements.Ensure compliance with company quality systems, safety procedures, and applicable regulatory requirements including GMP/cGMP, FDA, and ISO standards.
• Train manufacturing personnel on new processes, equipment, and standardized work procedures.
• Prepare technical reports, engineering documentation, and project status updates.

Requirements

• Bachelor's degree in Manufacturing Engineering, Mechanical Engineering, Industrial Engineering, Chemical Engineering, Biomedical Engineering, or a related engineering discipline.
• 25 years of manufacturing or process engineering experience.
• Experience supporting manufacturing operations in regulated or high-volume production environments.
• Knowledge of Lean Manufacturing, Six Sigma, and Continuous Improvement methodologies.
• Experience with process validation, root cause analysis, and problem-solving techniques.
• Strong understanding of manufacturing documentation and engineering change processes.
• Excellent analytical, organizational, and communication skills.
• Proficiency with Microsoft Office Suite.

Preferred Qualifications

• Experience in Medical Device, Pharmaceutical, Biotechnology, Automotive, Aerospace, or Electronics manufacturing.
• Knowledge of GMP/cGMP, FDA regulations, ISO 13485, ISO 9001, or AS9100.
• Experience with CAD software (SolidWorks, AutoCAD, Creo, or equivalent).
• Familiarity with ERP and Manufacturing Execution Systems (MES).
• Green Belt or Black Belt certification in Lean Six Sigma.
• Experience with automation, robotics, PLCs, or manufacturing equipment integration.